https://www.bmj.com/content/381/bmj-2022-073242“The Orphan Drug...

https://www.bmj.com/content/381/bmj-2022-073242

“The Orphan Drug Act, passed in 1983, aims to facilitate and financially incentivize the research and development of drugs for rare diseases with fewer than 200 000 affected US citizens. The Orphan Drug Act incentives include research grants for conducting clinical trials, tax credits of 25%, exemption from US Food and Drug Administration (FDA) user fees, and an enhanced marketing exclusivity of up to sevenyears after regulatory approval. “ It is “(potentially) the best healthcare legislation of the 20th century, the Orphan Drug Act encouraged the development of 6144 drug indications, of which 1035 received FDA approval since 1983”

https://www.rand.org/news/press/2024/02/01.html

@Artephius

As just pointed out by another excellent poster, Temcell is only sold in Japan as part of an licence agreement entered into by Osiris with JCR Pharma before Mesoblast acquired the IP.
The decision to hold off pricing in other markets is a straightforward commercial one . If you bother to read the 2024 findings of the latest Rand report into pricing differentials (link provided above) between the USA versus the rest of the world , you will understand that the US market will dominate sales per indication particularly in ODD. Why would Mesoblast make the amateur mistake of establishing lower pricing for a product in another territory like NZ or Canada , when they can be eligible for three to four times? higher pricing in the USA and be eligible for IP protection for seven years !

Perhaps do a little homework before lecturing us all.

Kind Regards

OP

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